Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

3001–3025 of 52938

HighFDA (Drugs)·D-0132-2026·2025-11-05
Testosterone and triamcinolone 37.5 mg pellets recalled over metal particulate matter
FarmaKeio Outsourcing is recalling 43,424 sterile Testosterone / Triamcinolone Acetonide 37.5MG/7.5MCG pellets over the potential presence of metal particulate matter.
Product
Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0380-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0119-2026·2025-11-05
Semaglutide 5 mg vials recalled for lack of sterility assurance
ProRx is recalling 2,805 vials of Semaglutide Injection 5 mg/2 mL from one lot for lack of assurance of sterility.
Product
Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-02
Category
Drug
Distribution
2 states
HighFDA (Devices)·Z-0321-2026·2025-11-05
Surgical imaging software recalled over image layer misalignment in 2D fusion
Surgical Theater is recalling 50 units of its PE SNAP imaging platform because a software anomaly may misalign secondary image layers against the primary layer.
Product
Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0106-2026·2025-11-05
Prazosin 5 mg capsules recalled over nitrosamine impurity above intake limit
Teva Pharmaceuticals USA is recalling 107,673 units of Prazosin Hydrochloride Capsules 5 mg because test results for N-nitroso Prazosin impurity C exceeded the acceptable intake limit.
Product
PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0350-2026·2025-11-05
ChemoLock ports recalled because the port weld may separate and leak
ICU Medical is recalling 133,255 ChemoLock Ports because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemoLock Port REF: CL2100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0365-2026·2025-11-05
Chemotherapy vial adapters recalled because port weld may separate and leak
ICU Medical is recalling 202,900 ChemosafeLock Vial Adapters because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0133-2026·2025-11-05
Testosterone and triamcinolone 50 mg pellets recalled over metal particulate matter
FarmaKeio Outsourcing is recalling 64,924 sterile Testosterone / Triamcinolone Acetonide 50MG/10MCG pellets over the potential presence of metal particulate matter.
Product
Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0365-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0375-2026·2025-11-05
CT scanners recalled over six software faults affecting movement and dose
Philips Medical Systems is recalling 105 Incisive CT scanners on software versions 5.1.0.X and 5.1.1.X over six software issues, including unintentional gantry and couch movement.
Product
Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;
Category
Medical Device
Distribution
18 states
HighFDA (Drugs)·D-0125-2026·2025-11-05
Testosterone 62.5 mg pellets recalled over potential metal particulate matter
FarmaKeio Outsourcing is recalling 829 sterile Testosterone 62.5 mg pellets from one lot over the potential presence of metal particulate matter.
Product
Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0367-2026·2025-11-05
Pyxis Medbank units recalled over fluid ingress causing smoke or fire
CareFusion is recalling 8,262 BD Pyxis Medbank units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.
Product
Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 138905-01 138906-01 138907-01 138908-01 138909-01 138910-01 138911-01 138912-01 138913-01 138914-01 138915-01 138916-01 138917-01 138918-01 13
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0308-2026·2025-11-05
Entry system accessories recalled over incomplete seals in sterile pouches
Alcon Research is recalling 1,632 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.
Product
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COU
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0368-2026·2025-11-05
Medication dispensing stations recalled over fluid ingress causing smoke or fire
CareFusion is recalling 2,755 BD Pyxis MedFlex units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.
Product
Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-01 139046-01 139049-01 139051-01 139052-01 139053-01 139054-01 139055-01 139056-01 139058-01 139059-01 139060-01 139061-0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0332-2026·2025-11-05
Integrated drip chamber administration sets recalled over port weld separation risk
ICU Medical is recalling 11,000 administration sets with a 20-drop integrated ChemoLock drip chamber because the port weld may separate or break during use and leak.
Product
ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0112-2026·2025-11-05
Desipramine 150 mg tablets recalled over nitrosamine impurity above intake limit
Heritage Pharmaceuticals is recalling 3,750 bottles of Desipramine Hydrochloride Tablets USP 150 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.
Product
DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0123-2026·2025-11-05
Testosterone pellets recalled over potential presence of metal particulate matter
FarmaKeio Outsourcing is recalling 1,329 sterile Testosterone 25 mg pellets from one lot over the potential presence of metal particulate matter.
Product
Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0389-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0311-2026·2025-11-05
Trocar sealing units recalled over silicone fragments detaching from sealing component
Aesculap is recalling 26 sealing units for 10/12mm trocars because silicone fragments may detach from the yellow sealing component.
Product
Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALING UNIT FOR 10/12MM TROCARS Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0307-2026·2025-11-05
Chandelier illuminators recalled over incomplete seals in the sterile pouch
Alcon Research is recalling 330 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.
Product
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000252 UNITY 27 GA CHANDELIER 8065000253 UNITY 27+DS WIDE ANGLE LIGHT PROBE Softwa
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0143-2026·2025-11-05
Sodium chloride injection bags recalled over potential flexible container leaks
Otsuka ICU Medical is recalling 509,360 100 mL bags of 0.9% Sodium Chloride Injection from one lot for lack of assurance of sterility due to potential flexible container leaks.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0305-2026·2025-11-05
Infusion line packs recalled over incomplete seals in sterile pouches
Alcon Research is recalling 25,778 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.
Product
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0146-2026·2025-11-05
Roasted mixed nuts recalled over hazelnuts missing from the allergen statement
Severn Peanut Company is recalling 528 cases of 8 oz Roasted No Salt Mixed Nuts after finding hazelnuts were not listed in the allergen statement.
Product
MIXED NUTS Roasted No Salt NET WT 8 OZ (227g) INGREDIENTS: ALMONDS, WALNUTS, PEANUTS***CASHEWS***HAZELNUTS, BRAZIL NUTS CONTAINS: ALMONDS, BRAZIL NUTS, CASHEWS, PEANUTS, WALNUTS UPC 8 10111 02237 8 DIST BY: HAMPTON FARMS 180 AVOCADO ST. SPRINGFIELD, MA 01104
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-0414-2026·2025-11-05
Nasal test kits recalled after a false negative on a positive sample
Cepheid is recalling 4,132 Xpert SA Nasal Complete kits after post-market half-time stability testing produced a false negative result for a positive sample type.
Product
Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0360-2026·2025-11-05
Graduated adapter extension sets recalled over port weld separation risk
ICU Medical is recalling 5,700 7.5-inch extension sets with a ChemoLock port and graduated adapter because the port weld may separate or break during use and leak.
Product
ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0322-2026·2025-11-05
SyncAR navigation platform recalled over image layer misalignment in 2D fusion
Surgical Theater is recalling 14 units of its SyncAR SNAP platform because a software anomaly may misalign secondary image layers against the primary layer.
Product
SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0342-2026·2025-11-05
Double port syringe transfer sets recalled over port weld separation risk
ICU Medical is recalling 4,000 Double ChemoLock Port Syringe Transfer Sets because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0343-2026·2025-11-05
Universal vented vial spikes recalled over port weld separation risk
ICU Medical is recalling 16,850 ChemoLock Universal Vented Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
Category
Medical Device
Distribution
Distributed nationwide